Gynecological Surgery and the Robot

Engineering, 2014, 6, 59-70 Published Online February 2014 (http://www.scirp.org/journal/eng) http://dx.doi.org/10.4236/eng.2014.62009

O. E. O’Sullivan, B. A. O’Reilly Department of Urogynecology, Cork University Maternity Hospital, Cork, Ireland Email: [email protected]

Received November 3, 2013; revised December 3, 2013; accepted December 10, 2013

Copyright © 2014 O. E. O’Sullivan, B. A. O’Reilly. This is an open access article distributed under the Creative Commons Attribu- tion License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. In accordance of the Creative Commons Attribution License all Copyrights © 2014 are reserved for SCIRP and the owner of the intellectual property O. E. O’Sullivan, B. A. O’Reilly. All Copyright © 2014 are guarded by law and by SCIRP as a guardian.

ABSTRACT As the only robotic device with FDA approval for gynecological surgery, the da Vinci® Surgical System domi- nates robot-assisted surgery in the field. Benefits to the Surgeon include decreased risk of neck and back injury secondary to improved ergonomics. However, patients benefit greatly due to decreased length of stay, decreased blood loss and analgesic requirements. Unfortunately the initial economic impact of purchasing and maintaining a robot is great but must be balanced with the potential savings from reduced length of stay and earlier return to normal activity. This article looks at the indications for robot-assisted surgery in gynecology. Assessing the effi- cacy of this modality compared to both straight stick (Laparoscopy) and open procedures. We discuss the impact and implications for surgical training imposed by robotic surgery. Furthermore, we assess the safety of robotic surgery from both the surgeons prospective and as a surgical modality.

KEYWORDS da Vinci Surgical System; Gynecology; Training; Ergonomics

1. Introduction and adnexal surgery [3,4]. The benefits for the Surgeon include the potential for greater precision, lower error Surgical Robots were developed to facilitate minimally rates, shorter learning curves and superior ergonomics invasive surgery and to assist surgeons in performing than conventional laparoscopy. procedures that would otherwise not be possible using Robot-assisted surgery is associated with clinical ben- traditional open or laparoscopic techniques [1]. DARPA efits for the patient such as reduced estimated blood loss (Defense Advanced Research Projects Agency) while (EBL), decreased blood transfusion requirements, shorter funding research into the possibility of a remote surgery length of stay (LOS), reduced peri-operative pain and program targeted toward battlefield triage aided the de- ® analgesic requirements. The Health Technology Assess- velopment of robotic surgery. The da Vinci Surgical ments (HTAs) conducted worldwide have agreed in prin- System (Intuitive Surgical, Inc., Sunnyvale, CA) was ciple that robotic surgery is indeed associated with bene- introduced to the market in 1999 and in 2000 it was fits in terms of reduced blood loss, decreased transfusion cleared by the FDA (Food and Drug Authority) for mi- rate, reduction in complication rates and a reduction in nimally invasive surgery. However, it didn’t gain FDA the length of stay [5-7]. With regard to health economics, approval for gynecological surgery until 2005, while in the current robotic surgical platform has been criticized Europe it has had full regulatory clearance and the CE due to its cost with no regard given to the benefits to so- (Conformité Européenne) mark since 1999 [2]. Over the ciety in terms of shorter duration of stay, reduced peri- past eight years, the role of the robot has expanded expo- operative complications and reduced transfusion re- nentially with many gynecological procedures now being quirements. Furthermore, there is the potential for earlier performed with robot assistance, including prolapse sur- return to work as a consequence of reduced pain and gery (sacrocolpopexy/hysteropexy), myomectomy, tubal analgesic requirements. As of December 31, 2012, there surgery, endometriosis surgery, hysterectomy (benign were 2585 da Vinci® Surgical Systems installed in ap- and malignant), cervical surgery (benign and malignant) proximately 2025 hospitals worldwide with approximately

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450,000 robot-assisted procedures across all surgical fields 3. Robot-Assisted Gynecological Surgery performed in 2012, an increase of approximately 25% 3.1. General Gynecology: Hysterectomy: Benign compared to 2011 [8]. and Malignant 2. What Is da Vinci® Surgical System? One of the first publications regarding robot-assisted ® hysterectomy was in 2006 by Reynolds [9]. Studies have The da Vinci Surgical System, since it was first intro- shown that robot-assisted hysterectomy is associated duced has undergone modifications and upgrades to the with a reduction in estimated blood loss [10-27], com- newer models with four arms, high definition (HD) im- plication rates [10-14,16-30] and reduced length of stay aging with improved visual capabilities and dual console [10-30] but is associated with longer operating times capabilities to facilitate training. In brief the System con- [10-22,24-30] when compared with the open approach. sists of three main components: the ergonomically de- Compared to traditional laparoscopy the robot-assisted signed console from where the Surgeon controls the op- approach is associated with decreased operating times eration, the patient side cart with four interactive robotic [12], reduced EBL, complication rates and conversion arms to which the operating instruments are attached and rates [10,12,14,20,23,29,31-41]. The most telling benefit the high performance vision system (Figure 1). The En- to robot-assisted hysterectomy is that fewer errors are ® doWrist instruments used during surgery combine 7 made compared with the laparoscopic approach [37]. degrees of freedom, with 90 degrees of articulation to Robot-assisted hysterectomy has been successfully used provide a range of motion superior to the human hand. in the treatment of locally advanced cervical cancer Surgical dexterity is further improved by combining in- [42,43]. However with regard to gynecological cancer tuitive motion and fingertip control with motion scaling surgery recent studies with long-term outcomes report a and tremor reduction technology. The principle of robot- potential complication of port site metastasis one re- ic surgery is that the surgeon operates unscrubbed while ported incidence is 1.9%. Women with ≥stage III endo- seated at the console, from which they are able to view metrial cancer, high-grade histology and women with the operating field in three dimensions through a ste- node positive cervical cancer had a significantly higher reoscopic viewer. It combines the benefits of laparos- risk of developing a port-site metastasis. Notably, port- copic surgery with ergonomic and technical advantages site metastases were four times more likely to occur in a to the Surgeon. specimen-retrieval port. The median time to occurrence

OPEN ACCESS ENG O. E. O’SULLIVAN, B. A. O’REILLY 61 of a port-site metastasis was 6 months [44]. reported post laparoscopic and open myomectomy [54].

3.2. General Gynecology: Adnexal Surgery: 3.6. Fertility: Tubal Re-Anastomosis Benign and Malignant Bedaiwy et al. in their paper entitled Robotic tubal anas- With regard to the use of robotic technology in adnexal tomosis: technical aspects, clearly outline the surgical surgery Magrina analyzed the use of robotic, laparoscopy technique and principles aided by detailed illustrations and laparotomy for secondary cytoreduction for recurrent [55]. There are few published studies assessing the role ovarian cancer [45]. No differences were observed among of robot-assisted surgery in fertility. A non-randomized the three groups for operating time, complications, com- cohort study comparing open to robot-assisted tubal re- plete debulking and survival. However, laparotomy anastomosis found the robot-assisted approach was asso- seemed preferable for patients with widespread perito- ciated with a longer operative time and a shorter LOS. neal implants, multiple sites of recurrence and/or exten- The robotic approach was associated with higher tubal sive adhesions [46]. pregnancies (4 vs. 1) and a lower rate of spontaneous pregnancies (2 vs. 1) despite a follow-up time of only 8.9 3.3. General Gynecology: Endometriosis Surgery months [56]. A recent paper aimed at comparing effectiveness and safety over the three surgical modalities Robot-assisted approaches had reportedly been used for found no data for evaluation from across multiple data- endometriosis surgery [47], Siesto in the largest series bases. They concluded a RCT was required to answer published regarding robot-assisted surgery for deep infil- this question [57]. trating endometriosis concluded robot-assisted surgery is a safe and attractive alternative to accomplish a compre- 3.7. Fertility: Interval Cervical Suture Placement hensive surgical treatment especially when bowel or bladder resections are required [48]. In 2007 the first case report of robot-assisted abdominal cerclage was published. Since then case reports have 3.4. Pediatric Gynecology confirmed the robotic approach is associated with short duration of stay, minimal blood loss [58] Robotic Sutures Recent publications suggest a role for robot-assisted sur- have been placed at the time of robot-assisted radical gery for pediatric gynecology. One paper from Italy re- trachelectomy [59] and also during pregnancy [60] with ported on six pediatric robot-assisted surgeries for ad- no additional perioperative complications. Persson et al. nexal pathologies. They concluded that the initial results identified that cervical suture placement at the time of suggest the robotic approach is safe in the pediatric pop- robot-assisted trachelectomy is significantly more precise ulation however further studies are required to assess the [61]. safety and the limits of the approach [49]. Case reports have been published detailing successful pregnancies following robot-assisted suture placement 3.5. Fertility: Myomectomy [62,63]. Gobern et al. compared myomectomy across the three surgical modalities of robot-assisted, laparoscopic and 3.8. Urogynecology: Sacrocolpopexy and open, they concluded the robot-assisted approach was Hysteropexy associated with longer operating times, shorter hospital The abdominal sacrocolpopexy remains the gold stan- stay and reduced blood loss [50]. Other studies have con- dard for the treatment of vaginal vault prolapse (VVP) firmed the longer operating time and shorter length of despite the introduction of newer techniques such as va- stay [51,52]. Of note myomectomies are notorious for ginal mesh kits [64]. Laparoscopic sacrocolpopexy has blood loss especially if multiple leiomyomata require been shown to have similar outcomes with re-operation excision. The EBL was lower in the robot-assisted group rates of approximately 6% - 7% and a mesh erosion rate compared to the open. Griffin et al. specifically assessed of 3% [65]. Furthermore, conversion rates reduced with postoperative outcomes confirming there was a shorter increased operator experience [65]. To date there is only length of stay and return to work associated with the ro- one randomized controlled trial comparing laparoscopic bot-assisted approach compared to the open approach, with robotic sacrocolpopexy there was no functional dif- however, it was also associated with greater residual fi- ferences between the two groups, the robot was asso- broid burden when measured twelve weeks after surgery ciated with increased cost, increased operative time and [53]. With specific regard to fertility post robot-assisted pain. [66]. A further study by White comparing three myomectomy, of 872 women undergoing myomectomy approaches, robotic, laparoscopic and single port re- 107 conceived resulting in 127 pregnancies and 92 deli- vealed no difference in pain, length of stay, blood loss or veries. The uterine rupture rate was 1.1% similar to those operating time between the three [67], with good short-

OPEN ACCESS ENG 62 O. E. O’SULLIVAN, B. A. O’REILLY term functional outcomes. Further studies confirm the cord malfunction (18%), instrument failure (10%), power good functional results using the robot showing it to be failure (9%), port problems (18%) and miscellaneous efficacious in the management of VV P [68,69] with a (27%). All surgeons performing robotic surgery must low complication rate and high patient satisfaction [70]. become familiar with troubleshooting robotic technology The robotic approach may assist the surgeon in dissect- and associated equipment. Failure to do so may add time ing over the sacral promontory [71]. A drawback to the and technical difficulty to robotic cases [84]. The FDA laparoscopic approach is the associated technical diffi- maintains a database of manufacturer and user facility culty in placing sutures [72]. While, open sacrocolpo- device experience (MAUDE) where all users of devices pexy is generally associated with greater blood loss, report robot malfunctions and there outcomes. In 2008, a longer hospital stay, delayed return of bowel function, review of the MAUDE database identified 168 reported increased postoperative pain and wound complications cases of robot malfunction approximately of which 4.8% [73]. were associated with patient injury. However, with time Hysteropexy utilizes many techniques and approaches MAUDE database reported incidences of instrument to restore uterine anatomy where uterine preservation is failure have increased with 528 reports of 565 instrument required [74]. Success rates are similar for all three ap- failures over two years from January 2009 and December proaches (open/laparoscopic/robot-assisted) varying from 2010. Friedman et al. divided the instrument failures into 87% - 98% [75-77]. Successful pregnancies have been five groups depending on the reported failure: 1: Wrist or reported following laparoscopic hysteropexy however the tool-tip failures (285), 2: Cautery instrument failures long-term effects of pregnancy on the surgery are not (174), 3: Instrument shaft failures (76), 4: Cable failure fully appreciated yet [78]. Lee et al. in their study on the (29) and 5: control housing failures (1) [85]. In general safety and feasibility of sacrohysteropexy for the treat- surgery in a single university unit Buchs et al. recorded a ment of prolapse concluded that the surgery was asso- robotic malfunction rate of 3.4% (18/526) over a sev- ciated with minimal blood loss and had excellent subjec- en-year period. Instrument failure accounted for 50% tive and objective success rates making it a safe and (9/18) of cases, 22% (4/18) occurred due to robotic ARM feasible surgical option in the management of pelvic or- failures, 16% (3/18) derived from console errors, the gan prolapse where uterine preservation is required [79]. remaining 12% (2/18) failure occurred in the optic unit. Of note the failure rate decreased with increased operator 3.9. Urogynecology: Vesicovaginal Fistula and team experience [86]. Repair Patient positioning is of great importance to minimize the potential adversarial outcomes associated with long The robot-assisted approach has been used in the surgical operative times. In a single unit study nerve injury asso- management of vesicovaginal fistula repair. The robot ciated with positioning during urological robotic surgery technology allows a complicated laparoscopic procedure had an incidence of 6.6% worryingly 23% of these per- to be performed safely with good results. Vesicovaginal sisted passed six months. The injury rate was signifi- fistulae have been effectively treated using the robot- cantly affected by operative time and ASA group (Ame- assisted approach with minimal blood loss, short length rican Society of Anesthetists). Therefore, patients un- of stay and recurrence rates [80,81]. dergoing long surgeries should be counseled regarding 4. How Safe Is Robot-Assisted Surgery? the risk of nerve injury especially if they have multiple comorbidities [87]. The introduction of new technology brings new chal- Checklists have been used as an intervention to pre- lenges especially for the Surgeon and the theatre team. vent these failures by promoting a team-working culture, One of the major technical issues that may arise is a ro- standardizing practice, allowing the detection of potential bot malfunction dealing with these issues intraoperative- errors and improving patient safety as a whole. One ex- ly is challenging for the entire team. Thankfully this is ample is the WHO surgical safety checklist. Another uncommon, however it does occur highlighting the need example, the Healthcare Failure Mode and Effects Anal- to counsel patients and to have a contingency plan. Stu- ysis (HFMEA) protocol has been widely used across dies recommend conventional laparoscopic suturing organizations. HFMEA is a powerful systems evaluation skills should be maintained as a requirement on the cur- tool developed by the US Veterans Affairs National Cen- riculum thus allowing the surgery to continue using mi- tre for Patient Safety. It is a step-by-step process that nimally invasive approach if required [82]. The incidence involves the multidisciplinary team in identifying poten- of device failure rate is reported as 0.2% - 0.4% [83]. tial causes of error within a system through the use of Technical challenges faced by Surgeons performing ro- flow diagrams, hazards scoring and decision tree analysis. bot-assisted gynecological oncological procedures in- Potential errors are prioritized according to severity, fre- cluded robotic arm malfunction (18%), light or camera quency/probability, criticality, detectability and existing

OPEN ACCESS ENG O. E. O’SULLIVAN, B. A. O’REILLY 63 control measures. The final process includes taking steps specific surgical indications is limited, as the advantage to implement solutions, minimize errors and avoid ad- of robotic-assisted surgery significantly depends on the verse events [88]. In a recent study using the HFMEA type of the procedure [92]. specific hazards were identified, e.g. patient positioning, With obesity increasing throughout the developed port placement, robot docking/de-docking and robotic world patient habitus often precludes them from lapa- and laparoscopic equipment checks, which were consi- roscopic surgery, however they may have robot-assisted dered to be important in robot-assisted urological proce- surgery performed with similar benefits. More complex dures and which are not extensively covered by other procedures can be undertaken robotically than with tradi- checklists [89]. A robot-specific checklist was developed tional straight stick surgery. which was specific to the unit with the aim of allowing the detection of potential errors and improving patient 6. Robot-Assisted Surgery Learning Curves safety as a whole. Units where robot-assisted surgery is Three distinct phases exist in the learning curves asso- performed need to implement safety checklists and en- ciated with robot-assisted surgery [96]. With regard to sure theatre teams are trained in troubleshooting for colorectal surgery the first phase or the initial phase oc- technical malfunctions thereby decreasing the potential curred over the first 15 cases during this phase the oper- negative impact of robotic surgery on patients. ating time decreased. The second phase or plateau phase 5. Which Approach Is Best for Surgeon occurred over the next ten cases, during this phase the Ergonomics? operator becomes more competent with the robotic technology. The third phase or the mastery phase occurred Robot-assisted surgery attempts to overcome some of the for the subsequent cases. During the mastery phase the limitations of laparoscopic surgery while retaining the complexity of the cases undertaken increased. The opera- benefits of a minimally invasive approach. Specific im- tive time may also increase reflecting the complexity of provements associated with robot-assisted surgery in- the surgical procedure. In gynecological surgery the clude better visualization through the use of three-di- learning curves range from 20 cases for hysterectomy mensional magnification, availability of tools with 7 de- and pelvic lymphadenopathy for endometrial cancer [97], grees of freedom that mimic hand movements along with 50 cases for benign hysterectomies [98], and 10 cases for improved ergonomics and more intuitive hand-eye coor- sacrocolpopexy [99]. Compared to this the learning curve dination when controlling surgical instruments [90-92]. associated with laparoscopic sacrocolpopexy is linear However, this has been achieved at the cost of haptic and and reported as between 18 - 24 cases [100]. A benefit of tactile feedback, as a result of the instruments being in- the robotic approach is that it maintains the benefits of directly manipulated by the surgeon [93]. laparoscopy while reducing the technical difficulties Lawson et al. [94] assessing the differences between [68,70,101]. musculoskeletal discomfort and ergonomic strain in la- Specific surgical techniques have also been assessed paroscopic versus robotic surgery for gastric bypass sur- with regard to their learning curves. A study comparing gery found that robotic cases were associated with more the learning curves for robot versus laparoscopic surgical discomfort in the neck, while laparoscopic cases were skills highlighted that with regard to suturing and dexter- associated with greater discomfort in the upper back and ity skills the robot allowed for quicker performance than in both shoulders. Furthermore, analysis of ergonomic laparoscopy [102]. Ng et al. made the following recom- positioning during the procedures found that laparoscop- mendations to shorten the learning curve. Firstly have a ic surgery was associated with poorer ergonomic posi- designated theatre team, with no introduction of new tioning of the upper arm, lower arm, wrist and wrist twist, members until 20 cases have been performed. Secondly, while robot-assisted surgery scored lower for trunk posi- patient positioning is of paramount importance and tioning [94]. While Craven et al. studied the ergonomic should be standardized for all cases and lastly familiari- deficits in robotic gynecologic oncology surgery reveal- zation with the instruments sets is required before any ing high rapid upper limb assessment RULA) survey deviation is considered [103]. scores, which correlated with high Strain index (SI) scores. The RULA survey is an ergonomic assessment 7. Training in Robotic Surgery and prioritization method for determining posture, force and frequency concerns with focus on the upper limb, Traditionally the surgical apprenticeship relied on the while the SI uses multiplicative interactions to identify Halstedian model of “see one, do one, teach one”. How- jobs that are potentially hazardous. They concluded that ever, with time the realization is there that this model is the deficits were hazardous to the surgeons and sug- inadequate to train surgeons to the highest level without gested a need for modification and intervention [95]. impacting on patient care [104]. The concept of training However the ability to generalize based on studies for and surgical education changed with the introduction of

OPEN ACCESS ENG 64 O. E. O’SULLIVAN, B. A. O’REILLY robotic surgery. Its appearance has created new chal- program [109]. lenges to ensure proper training and avoid subjecting patients to unnecessary risk. Increased scrutiny of cre- 7.2. Training Courses dentialing and medico-legal aspects of robotic surgery Training courses on robotic surgery are typically per- have reinforced the importance of training and have led formed using inanimate, animal, or cadaver models. The to a number of papers outlining pathways to facilitate this length of the course varies from several hours to several [105,106]. Learning tools for robotic surgery include: days, sometimes even weeks in a mini-fellowship situa- simulators, dual consoles, robotic courses and proctoring. tion. The content depends on the population on the course. Inanimate exercises offer a cost-effective and 7.1. Robotic Simulators robot-agnostic approach to training surgeons [110-112]. Buchs et al. in the World Journal of Surgery reviewed They can be designed to target specific (or a subset of) the learning tools and simulation in Robotic Surgery. technical skills needed to understand the basic functio- Even with a relative paucity of published reports on ro- nality of a robotic system [105,113]. With various levels botic simulators, and the lack of study in favor of one of difficulty, a continuum of inanimate exercises can simulator over another, the trend is clearly in favor of guide surgeons of different abilities through their initial virtual training [107]. Currently there are four commer- learning curves. Inanimate exercises for learning the cially available simulators. The Mimic dV-Trainer fundamentals of laparoscopic surgery can be expanded to (MdVT) (Mimic Technologies, Seattle, WA, USA) is a effectively target robot-specific skills [114]. In order to small, tabletop-sized, stand-alone simulator that repli- be useful training tools, inanimate exercises must both cates the da Vinci robot. The da Vinci Skills Simulator is challenge specific technical skills of using a robotic sur- the first virtual reality simulator produced by Intuitive gical system and have validated metrics so that surgeons Surgical that is integrated with the da Vinci Si console. It can accurately track their performance. [115]. For certain, integrates the Mimic virtual reality tasks using the da the advent of excellent surgical simulators and structured Vinci surgeon console as the user interface. The robotic inanimate exercises has provided tools for novice surge- surgical simulator (RoSS) system (Simulated Surgical ons to acquire console skills in a safe and structured en- Systems, Williamsville, NY, USA) was reported as being vironment. This will enhance their operating perfor- realistically close to the da Vinci console for virtual si- mance and reduce aspects of the learning curve such as mulation and instrumentation. Finally, the SEP-Robot operating time; however, the lack of availability of in (SimSurgery, Oslo, Norway) is another virtual robotic vivo training opportunities greatly limits the applicability simulator. It has a console connected to two instruments of this method of surgical training [116]. with seven degrees of freedom. Unlike the robotic system, however, the SEP-Robot does not provide three-dimen- 7.3. Dual Console sional images. Virtual reality simulation should be part of the robotic Introduction of the da Vinci Si system has given surge- curriculum, as should the use of a dual console, robotic ons a second robotic console, facilitating collaboration courses, and proctoring. Various societies for robotic between proctor and trainee. The mentoring console has surgery are currently at work on a clear curriculum for two collaborative modes: 1) the swap mode allows the the new generation of robotic surgeons, which hopefully mentor and trainee to operate simultaneously and active- will lead to standardization [107]. Trainees recognize the ly swap control of the robotic arms. 2) The nudge mode benefit of simulation training a questionnaire based study allows them to have control simultaneously, sharing the of a group of American urologic association trainees two robotic arms. concluded Trainees believe that the simulator replicates real-life robotic console movements and almost all be- 7.4. Live Surgery and Proctoring lieve they would be benefit from having access to robotic Live case observation remains an important component simulation [108]. Patient based training also has a nega- of a robotic training program [117] and allows the trainee tive impact on the cost of robotic surgery with specific to become familiar with the steps of a specific robotic regard to operating time and patient safety. Rehman et al. procedure. Proctoring is defined as direct supervision by performed a health economic evaluation of RoSS. During an expert during the initial phase of training and the the period of a year they assessed the time spent on the learning curve [117]. It provides a safe environment dur- RoSS console, they converted the time to training time ing the introduction of a new technique and prevents and assessed the loss of operating room time and revenue surgeons from performing procedures before they have if the RoSS was not available. They concluded the RoSS mastered the technique. is a cost effective surgical simulator for implementation The reality is that simulators, dual consoles, and ro- of a simulation-based robot-assisted surgical training botic courses should play an important role in bridging

OPEN ACCESS ENG O. E. O’SULLIVAN, B. A. O’REILLY 65 the gap between early surgical skills and effective per- sus OPen Surery and Laparoscopic Surgery: Clinical and formance using the robot in a clinical setting without Cost-Effectiveness Analyses,” 2010. subjecting patients to unnecessary risk. It is also impor- [6] C. S. Camberlin, A. Leys and M. De Laet, “Robot-As- tant to have tools that provide an objective means by sisted Surgery: Health Technology Assessment,” B.H.C.K.C. which to evaluate a trainee’s performance in anticipation (KCE), Editor, 2009. of their ultimate graduation [118]. Physicians in training [7] HIQA, “Health Technology Assessment of Robot-Assisted can acquire robotic surgery competency. Participants Surgery in Selected Surgical Procedures,” H.I.a.Q. 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